A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recruiting now · Phase 1/Phase 2
Conditions studied: Recurrent or Metastatic Solid Tumors
In brief
This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; cutaneous melanoma; and neuroendocrine carcinoma (NEC).
Key facts
- Study ID
- NCT06330064
- Run by
- Daiichi Sankyo
- People needed
- 680
- Starts
- 2024-04-10
- Expected to finish
- 2028-07-25
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd.
- Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., T-DXd) due to treatment-related toxicities.
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
- Inadequate treatment washout period before enrollment as specified in the protocol.
- Any history of interstitial lung disease (ILD)/pneumonitis, current ILD, or suspicion of ILD.
Where it is running
- Genesiscare North Shore Oncology — St Leonards, New South Wales, Australia (enrolling)
- Pih Health Hematology Medical Oncology — Whittier, California, United States (enrolling)
- Orchard Healthcare Research Inc — Skokie, Illinois, United States (enrolling)
- St Vincent'S Hospital Sydney — Mount Kuring-Gai, New South Wales, Australia (enrolling)
- NYU Langone Health — New York, New York, United States (enrolling)
- Icahn School of Medicine At Mount Sinai Prime — New York, New York, United States (enrolling)
- Clinical Research Alliance, Inc — Westbury, New York, United States (enrolling)
- White Plains Hospital — White Plains, New York, United States (enrolling)
- Erlanger Health, Inc — Chattanooga, Tennessee, United States (enrolling)
- Los Angeles Cancer Network — Los Angeles, California, United States (enrolling)
- SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
- Texas Oncology - West Texas — Amarillo, Texas, United States (enrolling)
- Texas Oncology, P.A. — Dallas, Texas, United States (enrolling)
- Texas Oncology Gulf Coast — Pearland, Texas, United States (enrolling)
- Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (enrolling)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
- Wenatchee Valley Hospital and Clinics — Wenatchee, Washington, United States (enrolling)
- Centro de Investigaciones Medicas Mar Del Plata — Mar del Plata, Buenos Aires, Argentina (enrolling)
- Hospital Aleman — Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina (enrolling)
- Hospital Sirio Libanes — Caba, Ciudad Autonoma Buenos Aires, Argentina (enrolling)
- The West Clinic — Germantown, Tennessee, United States (enrolling)
- M Health Fairview University of Minnesota Medical Center — Minneapolis, Minnesota, United States (enrolling)
- Centro de Investigaciones Medicas y Desarrollo LC SRL LC Investigacion — Ciudad Autonoma Buenos Aires, Argentina (enrolling)
- Blacktown Hospital — Blacktown, New South Wales, Australia (enrolling)
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
Full record on ClinicalTrials.gov
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